中华皮肤科杂志 ›› 2003, Vol. 36 ›› Issue (9): 501-504.

• 论著 • 上一篇    下一篇

咪喹莫特乳膏治疗尖锐湿疣随机、双盲、多中心研究

顾恒1, 曾凡钦2, 郭在培3, 彭振辉4, 毕志刚5, 朱学骏6, 陈昆1, 郭庆2, 张谊之3, 闫乎铃4, 张美华5, 韩钢文6, 常宝珠1, 刘训荃1, 王家璧7   

  1. 1. 中国医学科学院、中国协和医科大学皮肤病研究所, 南京210042;
    2. 中山大学第二医院;
    3. 四川大学华西医院;
    4. 西安交通大学第二医院;
    5. 南京医科大学第一附属医院;
    6. 北京大学第一医院;
    7. 中国医科大学附属第一医院皮肤科
  • 收稿日期:2003-04-01 出版日期:2003-09-15 发布日期:2003-09-15
  • 通讯作者: 常宝珠,E-mail:changbaozhu21805@sina.com E-mail:changbaozhu21805@sina.com

Treatment of Condyloma Acuminatum with Imiquimod Cream:A Randomized, Double-blind, Place-bo-controlled, Multi-central Clinical Trial

GU Heng1, ZENG Fan-qin2, GUO Zai-pei3, PENG Zhen-hui4, BI Zhi-gang5, ZHU Xue-jun6, CHEN Kun1, GUO Qing2, ZHANG Yi-zhi3, YAN Hu-ling4, ZHANG Mei-hua5, HAN Gang-wen6, CHANG Bao-zhu1, LIU Xun-quan1, WANG Jia-bi7   

  1. Institute of Dermatology, Chinese Academy of Medical Sciences&Peking Union Medical College, Nanjing 210042, China
  • Received:2003-04-01 Online:2003-09-15 Published:2003-09-15

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摘要： 目的 了解5%咪喹莫特乳膏治疗肛周和外生殖器尖锐湿疣的临床疗效和安全性。方法 采用随机、双盲、平行对照的临床研究方法,受试者每周3次外搽研究药物,疗程8周。疣体完全消退者继续随访1月以观察复发率。结果 共有258例肛周及外生殖器尖锐湿疣患者参加本次研究,其中5%咪喹莫特乳膏治疗组129例,安慰剂对照组129例。治疗后2、4、6、8周的痊愈率在治疗组分别为12.30%、32.79%、50%及60.66%,对照组分别为4.88%、14.63%、19.51%及26.02%,两组间差异有非常显著性(P<0.001);疗后2、4、6、8周的有效率在治疗组分别为36.89%、59.84%、68.03%及70.49%,对照组分别为13.82%、26.83%、32.52%及32.52%,两组间差异有非常显著性(P<0.001)。治疗组74例痊愈患者经随访1月后有4例复发,复发率为5.41%,与对照组相比差异无显著性。治疗组给药部位局部不良反应包括:红斑60.94%、水肿31.26%、糜烂42.96%、溃疡4.68%、灼热20.32%、疼痛36.72%、瘙痒17.18%。无系统不良反应。结论 5%咪喹莫特乳膏治疗肛周和外生殖器尖锐湿疣疗效好,安全性好,使用方便。

关键词: 尖锐湿疣, 投药,皮肤, 咪喹莫特

Abstract: Objective To observe the clinical efficacy and safety of 5% imiquimod cream in the topical treatment of condyloma acuminatum(CA).Methods A randomized,double-blind,parallel placebo-controlled clinical study was conducted.The test drug was topically used in CA patients,three times a week for 8 weeks.Patients whose warts cleared completely were followed up for one month to determine recurrence rates.Results Two hundred fifty-eight patients with anogenital warts were enrolled into this trial.One hundred twenty-nine patients were randomly selected to receive 5% imiquimod cream;129 patients were randomly chosen to receive placebo cream.Results showed that the cure rates were 12.30%,32.79%,50%,60.66% respectively in study group for 2,4,6,8 weeks and were 4.88%,14.63%,19.51%,26.02% respectively in control group for 2,4,6,8 weeks(P<0.001).The response rates were 36.89%,59.84%,68.03%,70.49% respectively in study group for 2,4,6,8 weeks and13.82%,26.83%,32.52%,32.52% respectively in control group for 2,4,6,8 weeks(P<0.001).Of imiquimod-treated patients whose warts cleared completely and who finished one month follow-up period,5.41%(4 of 74)experienced recurrences of warts.Side effect included erythema(60.94%),edema(31.26%),erosion(42.96%),ulceration(4.68%),burning(20.32%),pain(36.72%),itching(17.18%).There was no systemic side effect in two groups.Conclusions 5% Imiquimod cream in the topical treatment of anogenital warts is effective,safe and convenient.

Key words: Condylomata acuminata, Administration,cutaneous, Imiquimod